MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÀRL CODMAN CERTAS; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	82-8810PL
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was brought to the operating room for revision of ventricular shunt.A pre mri shunt dial xray was performed and setting noted at 4.Post mri shunt dial x-ray noted a change in setting to 6.Neurosurgery unable to adjust valve.Codman company rep present and unable to adjust valve.Shunt had to be surgically removed and replaced.

• Brand Name: CODMAN CERTAS
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÀRL; 325 paramount drive; raynham MA 02767
• MDR Report Key: 16156729
• Report Number: 16156729
• Device Sequence Number: 20577221
• Product Code: JXG
• UDI-Device Identifier: 10886704081890
• UDI-Public: (01)10886704081890
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/13/2022
• Report Date (Section F): 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-8810PL
• Device Catalogue Number: 828810PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 15 KG
• Date Report Sent to FDA: 12/13/2022